Golden Gate Study : Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

Trial Identifiers

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• NCT04994717
• 20190360, CT1470

Scientific Title

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

Commercial Sponsor

AMGEN

Summary

This study has a safety run-in part which will be performed prior to initiating the phase 3 randomised part of the study. The safety run-in aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy, and also evaluates a shorter dose step interval from 4 days (instead of 7 days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles. Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on Day 5 of the infusion for the remainder of the infusion. Once the safety run-in is complete, the randomised part oft he study will commence. This part has an Experimental Arm and an Active Comparator Arm. In the Experimental Arm, participants will receive Blinatumomab (intravenously) alternating with a low-intensity chemotherapy regimen. In the Active Comparator Arm, participants will receive 1 of 2 standard of care chemotherapy regiments (GMALL or HyperCVAD) per investigator's choice.